We believe our unique approach to monitoring plays a key role in separating us from other CROs. Our leadership team personally screens and selects each member of our monitoring team to ensure the right combination of clinical expertise, work ethic and knowledge of ICH GCP and regulatory requirements. Our monitors take a hands-on approach to developing a tailored plan that fits your trial’s unique needs and goals. From study startup to closeout, our experts take a personalized approach to ensuring every detail is followed through to completion.
Our monitoring services include:
- Site Qualification Visits
- Site Initiation Visits
- Site Closeout Visits
- On-site interim visits and remote interim visits
- Risk based monitoring
- Comprehensive Regulatory Review
More than project managers, our experts are your partners in starting and completing your trials on time and within budget. Our hand-selected project managers go beyond what is expected, communicating with you every step of the way and taking full ownership of each project to ensure proper planning, timely completion and thorough documentation.
Our project management services include:
- Investigator Recruitment
- Creation of a tailored monitoring plan that is thoroughly implemented
- Clinical trial tool development
- Close communication with internal project team and sponsor project team
- Managing and maintaining study timelines and communicating changes
Our clinical auditors review and ensure compliance of quality systems and best practices throughout the clinical trial development process, from the design of the protocol to the final clinical study report.
Our QA services include:
- Investigator and sponsor audits
- FDA audit preparation
- Providing ongoing quality assurance support and guidance to clinical operations
- GCP Training